Coronavirus COVID-19 Vaccines

RECENT UPDATES

• BioNTech/Pfizer BNT162 vaccine
  • FDA gives full approval for vaccine in adolescents 12 and older. [July 8]
  • FDA grants emergency use aurhtorization for vaccine in children less than 5 years old.[3][June 17]
  • FDA expands eligibility for booster vaccine to adolescents.[4][January 3]
  • US CDC recommends Pfizer and Moderna mRNA vaccines over Johnson & Johnson adenovirus vaccine.[5][December 16]
  • FDA expands eligibility for booster vaccine to all adults.[6] FDA authorized use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. [November 19]
  • FDA grants emergency use authorization for vaccination in children age 5–11.[7] Vaccine was 91% effective in preventing COVID-19 in this age group. Vaccine’s safety studied in 3,100 children age 5–11 and no serious side effects have been detected in the ongoing study. Dose recommendation is 10µg, one-third the dose given to those 12 and older.[8][October 29, November 9]
  • FDA authorizes third "booster" dose of BNT162 vaccine for certain populations - including individuals 65 and older and younger adults (1) at high risk for severe COVID-19 or (2) with high occupational exposure to COVID-19.[9][September 22, 2021]
  • Lower dose vaccine "safe and effective" in children between the ages of 5 and 11 according Phase 2/3 trial results reported in a company press release. Company to seek emergency approval for these ages “as soon as possible.”[10][September 20, 2021]
  • Vaccine fully approved by the U.S. FDA for individuals 16 years of age and older.[11] It remains under emergency use authorization (EUA) for individuals age 12–15 and for the administration of a third dose in certain immunocompromised individuals. [August 23, 2021]
  • Vaccine efficacy against Delta variant modestly lower than Alpha strain (88% vs 94%) after two doses according to study in the New England Journal of Medicine.[12] Efficacy difference in Delta vs Alpha strain was more pronounced after only one dose (36% vs 47%). [July 21, 2021]
  • Vaccine efficacy was 91% in fully vaccinated and 81% in partially vaccinated healthcare workers reported in New England Journal of Medicine.[13] Vaccinated individuals who developed COVID-19 had significantly lower viral load, shorter duration of virus detection, and less severe symptoms. [June 30, 2021]
  • Detailed safety and efficacy data in adolescents reported in New England Journal of Medicine.[14][May 27, 2021]
  • Vaccine receives Emergency Use Authorization for children 12–15 by U.S. FDA.[15] Although children and adolescents typically have milder Covid-19 symptoms than adults, more than 1.5 million U.S. cases have been reported in this age group. [May 10]
  • Approved for Emergency Use in the UK[16][December 2, 2021], Canada[17][December 9], United States[18][December 11], EU[19] [December 22], and other countries.
  • COVID-19 infection reduced by 95% in adult vaccine recipients according to Phase 3 trial results published in the New England Journal of Medicine.[20] In 43,548 participants, 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group. Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. [December 10, 2021]
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    • Large study from Israel published in NEJM showed low risk of adverse events – except for myocarditis, which occured 1 to 5 events per 100,000 persons (risk ratio compared to unvaccinated individuals: 3.24).[21] However, it was also found that the risk of myocarditis in persons infected with SARS-CoV-2 is much greater (risk ratio compared to uninfected individuals: 18.28). [August 25]
    • Vaccine 100% effective in preventing symptomatic Covid-19 in adolescents according to preliminary results of a Phase 3 trial in 2,260 adolescents 12 to 15 reported in a company press release.[22] The companies plan to submit these data to the FDA and EMA to expand emergency use of the vaccine in adolescents 12-15 years of age as quickly as possible. [March 31]
    • In correspondence to the editor published in NEJM the vaccine was found to be approximately two-thirds less effective at neutralizing the SARS-CoV-2 virus modified to have spike protein mutations similar to the B.1.351 (South Africa) variant.[23][February 17]
    • Results from a pre-print posted to bioRxiv indicate the vaccine is effective against the B.1.1.7 variant of SARS-CoV-2 first identified in the UK.[24][February 17]
    • Phase 3 study interim results reported in a company press release showed reduction of COVID-19 infection by 90% in vaccine recipients.[25] Results have not yet been published in a peer-reviewed journal. Study enrolled 43,538 participants to date and the first interim efficacy analysis was conducted when 94 COVID-19 cases were confirmed. The case split between vaccinated individuals and those who received the placebo indicated a vaccine efficacy rate above 90%, at 7 days after the second dose (given at day 28). No serious side effects were reported. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. [November 9]
    • Phase 1/2 trial published in Nature[26] showed that 60-person subset in immunized individuals generate a robust SARS-CoV-2-sepcific antibody and cellular mediated immune response which suggests multiple mechanisms with potential to protect against COVID-19. [September 30]
    • Phase 1/2 trial results published in Nature[27] showing that in 36 healthy adults 18–55 who received 2 doses of vaccine separated by 21 days developed RBD-binding and neutralizing antibodies higher than with natural infection. Mild to moderate side effects were common. [August 12; preprint published July 1]
    • U.S. government ordered 100 million doses of BNT162 for $1.95 billion as part of the U.S. Warp Speed program. A Phase 2b/3 safety and efficacy trial for the vaccine begins in late July 2020.[28][July 22]
• Moderna mRNA-1273 (Spikevax) vaccine
  • FDA grants emergency use aurhtorization for vaccine in children from 6 months old through age 17.[3][June 17]
  • FDA fully approves vaccine for individuals 18 years of age and older.[29] The vaccine previously known as the Moderna COVID-19 Vaccine will now be marketed as Spikevax. [January 31]
  • Veterans study shows lower risk of negative Covid-19 outcomes with mRNA-1273 (Moderna) over BNT162 (Pfizer) even though both are highly effective.[30][January 13]
  • US CDC recommends Pfizer and Moderna mRNA vaccines over Johnson & Johnson adenovirus vaccine.[5][December 16]
  • FDA expands eligibility for booster vaccine to all adults.[6] FDA authorized use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. [November 19]
  • FDA authorized a third dose of the Moderna vaccine for immunocompromised individuals [August 13], thenexpanded the authorization to include adults over the age of 65 [October 14].
  • Approved for Emergency Use in the US[18][December 18, 2021], Canada[31], EU[32], and the UK[33].
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    • In vitro neutralization studies not yet published in a peer-reviewed journal show vaccine activity against emerging strains of SARS-CoV-2.[34],[24] Moderna vaccine produced neutralizing titers against emerging variants including B.1.1.7 (first identified in the UK) and B.1.351 (first identified in South Africa [SA]). The vaccine produced neutralizing antibodies against B.1.1.7 (UK) at levels comparable to prior variants but neutralization antibody induction was 6-fold lower in the B.1.351 (SA) variant. Despite this reduction, the company believes that neutralizing titer levels with B.1.351 are still high enough to be protective. However, they plan to produce a vaccine booster targeted at the SA variant and begin a Phase 1 study of that booster within the next several months. [January 25, 2021]
    • COVID-19 infection reduced by 94% and severe COVID-19 reduced by 100% in vaccine recipients according to Phase 3 trial final results reported in the New England Journal of Medicine.[35] In 30,420 participants, 196 confirmed cases of COVID-19 were evaluated, with 185 observed in the placebo group versus 11 in the vaccine group. Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. [December 30, 2021]
    • Phase 3 study interim results reported in a company press release showed reduction of COVID-19 infection by 95% in vaccine recipients.[36] Results have not yet been published in a peer-reviewed journal. Study enrolled more than 30,000 participants to date and the first interim efficacy analysis was conducted when 95 COVID-19 cases were confirmed beginning two weeks after the second dose. Of these cases, 90 cases of COVID-19 were observed in the placebo group versus 5 in the vaccine group. Eleven severe cases were reported – all 11 cases occurred in the placebo group and none in the vaccine group. No serious side effects were reported. The trial is continuing to enroll and is expected to continue through the final analysis. [November 16, 2021]
    • Results of Phase 1 clinical trial in older adults (56+ years of age) published in the New England Journal of Medicine[37] showed a robust antibody and cellular immune response in vaccinated individuals. Mild-moderate side effects were common but self-limited. [September 29, 2021]
    • Preclinical study in non-human primates reported in New England Journal of Medicine.[38] Two injections elicited high levels of neutralizing antibody and Th1 CD4 T-cell responses in rhesus macaques. Two days after challenge of vaccinated animals with intranasal and intratracheal virus, viral replication was undetectable in bronchoalveolar-lavage fluid and nasal secretions. [July 28, 2021]
    • Phase 1 study published in NEJM.[39] Forty-five adults age 18–55 were tested with one of three dose levels given as 2 vaccinations 28 days apart. All subjects produced antibodies and neutralizing activity on par with natural infection. Mild-moderate side effects were common. [July 14, 2021]
• Novavax NVX-CoV2373 vaccine
  • FDA give emergency use authorization for vaccine in individuals 18 years of age and older.[40] [July 13]
  • EU gives conditional marketing aurhorization for Nuvaxovid vaccine.[41] [December 21]
  • Vaccine efficacy of 90% reported in Phase 3 trial published in the New England Journal of Medicine.[42]No serious infections occured in the vaccinated group. Side effects were generally mild and transient. [June 30]
  • Vaccine efficacy of 51% against S. Africa variant B.1.351 reported in Phase 2a-b trial in the New England Journal of Medicine.[43] Efficacy against the B.1.351 variant has previously been reported to be 64% with the J&J vaccine and 10% with the AstraZeneca vaccine. [May 5]
  • COVID-19 infection reduced by 96% for original strain and 86% for the B.1.1.7 (UK) variant strain in final Phase 3 trial results reported in a company press release.[44] The company expects the data to serve as the basis for submission for authorization to various regulatory agencies worldwide. [March 11]
  • In a separate study of 2,665 participants in South Africa, overall vaccine efficacy was 49% against predominantly the variant B.1.351 (South Africa) strain.[44][March 11]
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    • COVID-19 infection reduced by 89% in vaccine recipients according to Phase 3 trial interim results reported in a company press release.[45] Study enrolled ~15,000 participants and the first interim efficacy analysis was conducted when 62 COVID-19 cases were confirmed 7 days after a second vaccine dose. Preliminary analysis indicated that the UK variant strain that was increasingly prevalent was detected in over 50% of the PCR-confirmed symptomatic cases (32 UK variant, 24 non-variant, 6 unknown). Based on PCR performed on strains from 56 of the 62 cases, efficacy by strain was calculated to be 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain. [January 28]
    • Phase 3 trial begins with 10k participants in the UK.[46] A similar trial is expected to start in the U.S in October. [September 24]
    • Phase 1/2 trial published in New England Journal of Medicine[47] showed that in 106 healthy adults age 18–59 who received two doses spaced 21 days apart had robust immune responses with both IgG and neutralization antibodies 4-fold higher than seen in natural infection. Mild-moderate side effects were common and greater local and systemic reactogenicity occurred with the second dose. [September 2]
    • Received U.S. Warp Speed funding for protein-based vaccine development and clinical trials.[48][July 7]
• Johnson & Johnson/Janssen Ad26.COV2-S vaccine
  • FDA limits use of vaccine to adults who cannot or refuse to get the Pfizer-BioNTech or Moderna vaccines, citing safety concerns.[49][May 5]
  • Single dose provided 53% efficacy against moderate to severe Covid-19 in final analysis of randomized controlled trial.[50][February 9]
  • FDA authorizes second dose of this vaccine for all adults who received a first dose. [October 20]
  • Vaccine efficacy shown to be 94% against mild to severe Covid-19 with a second dose, up from 74 percent conferred with a single dose, the company reported in a press release.[51][September 21]
  • Vaccine distribution resumed in U.S. following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices.[52] To date 15 cases of thrombosis-thrombocytopenia syndrome (TTS) had been reported in the U.S., all cases occurring in women between the ages of 18 and 59, with a median age of 37 years, with onset 6–15 days after vaccination. Monitoring for safety will continue. [April 23]
  • COVID-19 infection reduced by 66% in vaccine recipients in Phase 3 ENSEMBLE trial published in the New England Journal of Medicine.[53] Study enrolled nearly 40,000 participants and the efficacy analysis was conducted when COVID-19 cases were confirmed 28 days after a single-dose vaccine. The onset of protection was observed as early as 14 days. Level of protection varied by geography likely due to different circulating SARS-CoV-2 strains: effectiveness was 72% in the US, 68% in Brazil, and 64% in South Africa. [April 21]
  • Approved for Emergency Use in the US.[54] United States FDA analysis showed vaccine had efficacy of 72% in the US, 64% in South Africa, and 61% in Latin America. [February 27]
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    • European Medicines Agency (EMA) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for this vaccine in the European Union, but that regulators in individual E.U. member states should decide how to proceed with vaccine authorization taking into account case loads and vaccine availability.[55][April 20]
    • Vaccine distribution paused by U.S. FDA and CDC while examining safety issues related to blood clotting.[56] Out of 6.8 million doses given in the U.S. to date, there have been 6 reported cases of cerebral venous sinus thrombosis (CVST) seen in combination with thrombocytopenia. All occurred in women between ages of 18 and 48, 6–13 days after vaccination. CDC’s Advisory Committee on Immunization Practices (ACIP) will meet to further review these cases and assess their potential significance. [April 13]
    • COVID-19 infection reduced by 66% in vaccine recipients in Phase 3 trial interim results reported in a company press release.[57] Study enrolled nearly 44,000 participants and the first interim efficacy analysis was conducted when 468 COVID-19 cases were confirmed 28 days after a single-dose vaccine. The onset of protection was observed as early as 14 days. Level of protection varied by geography likely due to different circulating SARS-CoV-2 strains: effectiveness was 72% in the US, 66% in Latin America, and 57% in South Africa. [January 29]
    • Trials resumed in the US after safety review by the company and an independent Data Safety Monitoring Board (DSMB) found no evidence that the vaccine candidate caused the medical event experienced by one study partipant.[58][October 23]
    • All trials of this vaccine paused (including Phase 3 trial)[59] due to an unexplained illness in a study participant. The company and a DSMB are investigating. [October 12]
    • Phase 3 trial (ENSEMBLE) begun with 60,000 participants from multiple country.[60][September 23]
    • Preclinical study in rhesus macaques reported in Nature[61] showed a single dose of the adenovirus serotype 26 (Ad26) vector-based vaccine induced robust neutralizing antibody responses and provided complete or near-complete protection in bronchoalveolar lavage and nasal swabs following SARS-CoV-2 challenge. [July 30]
    • Phase 1/2 trial began in late July.
    • The company received Warp Speed funding of $456 million for pre-clinical and Phase 1 clinical trials. [March 30]
• University of Oxford / AstraZeneca AZD1222 vaccine
  • Vaccine efficacy against Delta variant modestly lower than Alpha strain (67% vs 74%) after two doses according to study in the New England Journal of Medicine.[12] Efficacy difference in Delta vs Alpha strain was more pronounced after only one dose (30% vs 49%). Overall efficacy of the AZD1222 vaccine was lower than the BNT162 vaccine. [July 21]
  • Rare side effect of thrombosis and thrombocytopenia found with this vaccine reported to be associated with detection of antibodies to platelet factor 4 (PF4).[62] Patients with post-vaccination thrombosis should therefore not be treated with platelet transfusion or heparin, which can worsen thrombosis. [April 16]
  • Company restated trial data and vaccine efficacy as 76%[63] after criticism from the Data and Safety Monitoring Board (DSMB) and U.S. National Institutes of Health (NIH) that the company may have included outdated information in its initial press release, overstating the vaccine efficacy.[64] Company reported more current data after the accrual of 190 cases of symptomatic Covid were seen in 32,449 trial participants. Results were overall similar to the original report. [March 24]
  • Vaccine 79% effective in preventing symptomatic Covid-19 according to preliminary results of a U.S. Phase 3 trial reported in a company press release.[65] Study enrolled 32,449 participants and the interim efficacy analysis was conducted when 141 COVID-19 cases were confirmed. Efficacy was comparable across ethnicity and age. Vaccine was well tolerated and no increased risk of thrombosis seen – specifically, no cases of cerebral venous sinus thrombosis (CVST) were reported. [March 22]
  • Vaccine is safe and not associated with increased overall risk of thromboembolic events concluded the European Medicines Agency (EMA). However, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, with or without bleeding, including rare cases of cerebral venous sinus thrombosis (CVST) and disseminated intravascular coagulation (DIC) - 25 cases in 20 million vaccinations. A causal link with the vaccine is not proven, but is possible and deserves further analysis.[66][March 18] Denmark, Iceland, Norway, Germany, France, Italy and several other countries had suspend the use of the vaccine pending this review. [March 11]
  • Vaccine not protective against mild-to-moderate Covid-19 due to the B.1.351 (South Africa) variant according to a study in the New England Journal of Medicine.[67][March 16] South Africa had already suspended use of the vaccine when preliminary data from this study was reported.[68][February 8]
  • Approved for Emergency Use in the UK[69][December 30], EU[70][January 29], Canada [February 26], and other countries.
  • COVID-19 infection reduced by 70% in vaccine recipients according to Phase 3 trial interim results reported in the Lancet.[71][December 8]
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    • Study published on a Lancet pre-print server[72] revealed vaccine efficacy of 67% overall with no hospitalizations in the vaccine group 22 days after the first dose. Efficacy appeared to be enhanced (82%) if the second dose was given 12 weeks or more after the first dose. The study also showed that transmission of the virus by vaccine recipients, as measured by weekly PCR tests, was reduced by 67% after a single dose and 50% after the two dose regimen. [February 2]
    • Phase 3 trial interim results reported in a company press release showed reduction of COVID-19 infection by 70% in vaccine recipients.[73] Based on these results, the company intends to submit for an Emergency Use Authorization (EUA) with the World Health Organization in coming weeks. [November 23]
    • Phase 3 trial resumed in the US after safety review by the FDA.[74][October 23]
    • Phase 3 trial resumed in the UK[75] (where the case of transverse myelitis occurred) but not yet in the United States, due to safety concerns at the NIH and FDA. [September 12]
    • Phase 3 trial paused[76] due to a trial participant developing a serious neurological event, thought to be transverse myelitis.[77]Transverse myelitis is a rare disorder of the spinal cord that, like Guillain-Barré syndrome, can be triggered by certain viral infections, including SARS-CoV-2 itself. Investigators and the U.S. National Institutes of Health have pledged to fully investigate whether this case could be associated with the vaccine. [September 9]
    • Preclinical study in rhesus macaques reported in Nature[78] showed that a single vaccination with ChAdOx1 nCoV-19 is effective in preventing damage to the lungs upon high dose challenge to both upper and lower respiratory tract with SARS-CoV-2; there was also no evidence of immune-enhanced disease in vaccinated animals. However, in regard to possible infectivity, nasal shedding of the virus was not significantly different between vaccinated and control animals. [July 30]
    • Phase 1/2 trial published in Lancet[79] showed that in adults age 18–55 a single dose elicited both humoral and cellular responses against SARS-CoV-2, with a booster immunization augmenting neutralizing antibody titres. No serious adverse effect were reported; mild-moderate side effects were common. [July 20]
    • Phase 3 trials that are underway in Brazil, South Africa, and the UK.
• SinovacCoronaVac inactivated vaccine
  • COVID-19 infection reduced by 83% in adult vaccine recipients according to interim results of a Phase 3 trial published in the Lancet.[80] Vaccine was well tolerated. [July 8]
• Gamaleya Research Institute Gam-COVID-Vac vaccine
  • COVID-19 infection reduced by 92% in vaccine recipients according to Phase 3 trial interim results reported in the Lancet.[81] Study enrolled ~20,000 participants > age 18 in Moscow and the first interim efficacy analysis was conducted when 78 COVID-19 cases were confirmed 21 days after the first dose (the day of dose 2). Most reported adverse events were mild. 45 (0.3%) of 16,427 participants in the vaccine group and 23 (0.4%) of 5,435 participants in the placebo group had serious adverse events; none were considered associated with vaccination as confirmed by the independent data monitoring committee. [February 2]
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    • Phase 1/2 trial results published in Lancet[82] showed 76 adults receiving one of two vaccine types (rAd26-S or rAd5-S) either alone or with a booster at 21 days generated both neutralizing and specific IgG antibodies. Mild-moderate side effects (pain at injection site, fever, headache, myalgia) were common, but no major side effects were reported. [September 4]
    • Phase 1 trials of this vaccine were registered in June 2020 but no results have have been published in the scientific literature. Despite this, Russian President Vladimir Putin announced regulatory approval of the vaccine (to be called "Sputnik V" in foreign markets). Mass vaccination in Russia is expected to start in October 2020.[83][August 11]
• INOVIO INO-4800 vaccine
  • Phase 2/3 has been put on partial clinical hold until questions posed by the U.S. FDA about the candidate and the delivery device (CELLECTRA® 2000) have been satisfactorily addressed. This hold is not due to the occurrence of any adverse events. [September 28]
  • Reports in a press release success of DNA-based vaccine INO-4800 in Phase 1 trial.[84][June 30]
• Wuhan Institute of Biological Products / Sinopharm β-propiolactone-inactivated-whole-virus vaccine
  
  • Interim analysis of a Phase 1/2 trial reported in JAMA[85] showed that in 225 healthy adults aged 18–59 two injections of a medium dose spaced 21 days apart generated the most neutralizing and specific IgG antibodies and those levels were reported to be comparable to other vaccine candidates (but no direct comparisons was made to those vaccines or to convalescent plasma). Side effects were mild, self-limited and lower in frequency than what has been reported for other vaccine types. [August 13]
• CanSino Biologics Adenovirus Type 5 vectored vaccine
  • Phase 2 trial published in Lancet[86] showed that in 382 adults age ≥ 18 a single dose induced cellular or humoral immune responses at day 28 post vaccination in 91–95% of recipients depending on the dose. Mild-moderate side effects were common; Grade 3 adverse effects were seen in 9%. [July 20]
  • Received Military Specially-needed Drug Approval (軍隊特需藥品批件) for non-replicating adenovirus vaccine Ad5-nCoV for use in the Chinese military.[87][June 25]

Pfizer / BioNTech
BNT162b2, Tozinameran, Comirnaty

44k

95%[20]

UK: 2-Dec[16]
CA: 9-Dec[17]

US: 11-Dec[18]; Full approval: 23-Aug

EU: 22-Dec[19]

2

21

mRNA

-70ºC

Moderna
mRNA-1273

30k

94%[35]

US: 18-Dec[88]

CA: 23-Dec[31]

EU: 06-Jan[32]

UK: 08-Jan[33]

2

28

mRNA

2–8ºC

Johnson & Johnson
Ad26.COV2.S, JNJ-78436735

44k

66%[53]
91% (second dose)[51]

US: 27-Feb[54];
Paused 13-Apr[56]

Resumed 23-Apr[52]

CA: 05-Mar

EU: 11-Mar

1

-

Adenovirus

2–8ºC

AstraZeneca / Oxford
AZD1222

24k

67%[71],[72]

UK: 30-Dec[69]

AR: 30-Dec

IN: 03-Jan

MX: 04-Jan

BR: 17-Jan

EU: 29-Jan[70]

CA: 26-Feb

2

28

Adenovirus

2–8ºC

Gamaleya Research Institute
Gam-COVID-Vac (Sputnik V)

20k

92%[81]

RU: 11-Aug[89]
MX: 03-Feb

2

21

Adenovirus

-18ºC

Sinovac
CoronaVac

26k

83%[80]

CN: 29-Dec

2

14

Inactivated

2–8ºC

Novavax
NVX-CoV2373

30k

90%[42]

2

21

Protein Subunit

2–8ºC

Sinopharm
Inactivated virus, BBIBP-CorV

50k

72% (self report)

CN: 25-Feb

2

21

Inactivated

Bharat Biotech
BBV152

25k

Not yet reported

IN: 03-Jan

2

14

Inactivated

CanSino Biologics
Ad5-nCoV

40k

65% (self report)

CN: 25-Feb

1

-

Adenovirus

2–8ºC

CureVac AG
CVnCoV

2

28

Protein Subunit

Trial = # of Phase 3 trial participants; Phase 3 Efficacy = Vaccine Efficacy/Effectiveness (reduction in disease among the vaccinated group); Emergency Approval = Date of Emergency Use Authorization (EUA); # = Number of Doses Required; US = United States; UK = United Kingdom; CA = Canada; EU = European Union; AR = Argentina; IN = India; MX = Mexico; CN = China; BR = Brazil

Recipient of U.S. Operation Warp Speed Funding

Pfizer / BioNTech/
BNT162

NCT04368728
Results in NEJM[90]

NCT04537949
Results in Nature[27]

NCT04537949
Positive final results.[25],[91]

Moderna/ NIAID
mRNA-1273

NCT04283461
Results in NEJM[39],[37]

NCT04405076

NCT04470427

Positive final results.[36],[92]

University of Oxford/ AstraZeneca
AZD1222

NCT04324606
Results in Lancet[93]

NCT04516746
Positive interim results.[73]

Sinovac
CoronaVac

NCT04383574
NCT04352608
Results in Science[94]

NCT04456595

Wuhan Institute of Biological Products/ Sinopharm
Inactivated virus

ChiCTR-2000031809
Results in JAMA[85]

ChiCTR-2000034780

Beijing Institute of Biological Products/ Sinopharm
BBIBP-CorV

ChiCTR-2000032459
Results in Lancet Infect Dis[95]

ChiCTR-2000034780

Bharat Biotech
BBV152

CTRI/2020/07/026300

CTRI-2020/11/028976

CanSino Biological Inc/ Beijing Institute of Biotechnology
Ad5-nCoV

NCT04313127
Results in Lancet[96]

NCT04341389
Results in Lancet[86]

NCT04526990; NCT04540419

Gamaleya Research Institute
Gam-COVID-Vac, Sputnik V

NCT04437875;
Results in Lancet[82]

NCT04587219

NCT04530396

Janssen Pharmaceutical Companies
Ad26.COV2.S

NCT04436276

NCT04505722

Novavax
NVX-CoV2373

NCT04368988
Results in NEJM[47]

2020-004123-16

*Trials spanning Phase 1 and 2 represent Phase 1/2 trials.

Moderna/ NIAID

RNA

LNP-encapsulated mRNA (mRNA-1273)

Phase 3 NCT04470427; Positive final results.[36],[92]

Phase 2 NCT04405076

Phase 1 NCT04283461; Results in NEJM[39],[37]

BioNTech/ Fosun Pharma/ Pfizer

RNA

3 LNP-mRNAs (BNT162)

Phase 3 NCT04368728; Positive final results.[25],[91]

Phase 1/2 NCT04537949; Results in Nature[27]

University of Oxford/ AstraZeneca

Non-Replicating Viral Vector

Weakened adenovirus (ChAdOx1-S; AZD1222)

Phase 3 NCT04516746; Positive interim results.[73]

Phase2b/3 NCT04400838

Phase 1/2 PACTR202006922165132; 2020-001072-15; Results in Lancet[96]

Sinovac

Inactivated

Inactivated + alum (CoronaVac; formerly PiCoVacc)

Phase 3 NCT04456595

Phase 1/2 NCT04383574 ; NCT04352608; Results in Science[94]

Wuhan Institute of Biological Products/ Sinopharm

Inactivated

Inactivated

Phase 3 ChiCTR2000034780

Phase 1/2 ChiCTR2000031809; Results in JAMA[85]

Beijing Institute of Biological Products/ Sinopharm

Inactivated

Inactivated (BBIBP-CorV)

Phase 3 ChiCTR2000034780

Phase 1/2 ChiCTR2000032459

CanSino Biological Inc./ Beijing Institute of Biotechnology

Non-Replicating Viral Vector

Adenovirus Type 5 Vector (Ad5-nCoV)

Phase 3 NCT04526990; NCT04540419

Phase 2 NCT04341389; Results in Lancet[86]

Phase 1 NCT04313127; Results in Lancet[96]

Gamaleya Research Institute

Non-Replicating Viral Vector

Adenovirus-based (Gam-COVID-Vac; Гам-КОВИД-Вак)

Phase 3 NCT04530396

Phase 1 NCT04436471; NCT04437875; Results in Lancet[82]

Anhui Zhifei Longcom Biopharmaceutical/ Institute of Microbiology, Chinese Academy of Sciences

Protein Subunit

Adjuvanted recombinant protein (RBD-Dimer)

Phase 2 NCT04466085

Phase 1 NCT04445194

Inovio Pharmaceuticals / International Vaccine Institute

DNA

DNA plasmid vaccine with electroporation (INO-4800)

Phase 1/2 NCT04336410; NCT04447781

Novavax

Protein Subunit

Recombinant SARS CoV-2 glycoprotein nanoparticle vaccine adjuvanted with Matrix M (NVX-CoV2373)

Phase 3 2020-004123-16

Phase 2b NCT04533399

Phase 1/2 NCT04368988; Results in NEJM[47]

Janssen Pharmaceutical Companies

Non-Replicating Viral Vector

Ad26.COV2.S

Phase 3 NCT04505722

Phase 1/2 NCT04436276

Bharat Biotech

Inactivated

Whole-Virion Inactivated

Phase 1/2 CTRI/2020/07/026300

Kentucky Bioprocessing, Inc

Protein Subunit

RBD-based

Phase 1/2 NCT04473690

Institute of Medical Biology, Chinese Academy of Medical Sciences

Inactivated

Inactivated

Phase 1/2 NCT04470609

Phase 1 NCT04412538

Sanofi Pasteur/GSK

Protein Subunit

S protein (baculovirus production

Phase 1/2 NCT04537208

Research Institute for Biological Safety Problems, Rep of Kazakhstan

Inactivated

Inactivated

Phase 1/2 NCT04530357

SpyBiotech/Serum Institute of India

VLP

RBD-HBsAg VLPs

Phase 1/2 ACTRN12620000817943

Genexine Consortium

DNA

DNA Vaccine (GX-19)

Phase 1 NCT04445389

Cadila Healthcare Limited

DNA

DNA plasmid vaccine

Phase 1/2 CTRI/2020/07/026352

Osaka University/ AnGes/ Takara Bio

DNA

DNA plasmid vaccine + Adjuvant

Phase 1 JapicCTI-205328

Gamaleya Research Institute

Non-Replicating Viral Vector

Adenovirus-based (Gam-COVID-Vac; Гам-КОВИД-Вак)

Phase 1 NCT04436471; NCT04437875

Clover Biopharmaceuticals Inc./ GSK/ Dynavax

Protein Subunit

Native like Trimeric subunit Spike Protein vaccine (SCB-2019)

Phase 1 NCT04437875

Arcturus/Duke-NUS

RNA

mRNA

Phase 1/2 NCT04480957

Vaxine Pty Ltd/ Medytox

Protein Subunit

Recombinant spike protein with Advax™ adjuvant

Phase 1 NCT04453852

University of Queensland/ CSL/ Seqirus

Protein Subunit

Molecular clamp stabilized Spike protein with MF59 adjuvant

Phase 1 ACTRN12620000674932p

Imperial College London

RNA

LNP-nCoVsaRNA

Phase 1 ISRCTN17072692

Curevac

RNA

mRNA

Phase 1 NCT04449276

Medigen Vaccine Biologics Corporation/ NIAID/ Dynavax

Protein Subunit

S-2P protein + CpG 1018

Phase 1 NCT04487210

People’s Liberation Army (PLA) Academy of Military Sciences/Walvax Biotech

RNA

mRNA

Phase 1 ChiCTR2000034112

Medicago Inc./ Université Laval

VLP

Plant-derived VLP

Phase 1 NCT04450004

Institute Pasteur/ Themis/ Univ. of Pittsburg CVR/ Merck Sharp & Dohme

Replicating Viral Vector

Measles-vector based

Phase 1 NCT04497298

ReiThera/ LEUKOCARE/ Univercells

Non-Replicating Viral Vector

Replication defective Simian Adenovirus (GRAd) encoding S

Phase 1 NCT04528641

Instituto Finlay de Vacunas, Cuba

Protein Subunit

RBD + Adjuvant

Phase 1 IFV/COR/04

FBRI SRC VB VECTOR, Rospotrebnadzor, Koltsovo

Protein Subunit

Peptide

Phase 1 NCT04527575

West China Hospital, Sichuan University

Protein Subunit

RBD (baculovirus production expressed in Sf9 cells)

Phase 1 ChiCTR2000037518

University Hospital Tuebingen

Protein Subunit

SARS-CoV-2 HLA-DR peptides

Phase 1 NCT04546841

COVAXX

Protein Subunit

S1-RBD-protein

Phase 1 NCT04497298

Beijing Wantai Biological Pharmacy/ Xiamen University

Replicating Viral Vector

Intranasal flu-based-RBD

Phase 1 ChiCTR2000037782

Vaxart

Non-Replicating Viral Vector

Ad5 adjuvanted Oral Vaccine platform

Phase 1 NCT04563702

Ludwig-Maximilians - University of Munich

Non-Replicating Viral Vector

MVA-SARS-2-S

Phase 1 NCT04569383

^†Adapted from Draft landscape of COVID-19 candidate vaccines. WHO. 22 December 2020.[1]

LNP = lipid nanoparticle; RBD = receptor-binding domain; mRNA = messenger RNA; VLP = virus-like particles

Recipient of U.S. Operation Warp Speed Funding[97],[98]